Identity
- Trade Name
- Faset FDA UDI
- Generic Name
- Bone marrow biopsy needle, single-use FDA UDI
- Device Name
- V-Pin Needle Set_Triple FDA UDI
- Model / Reference
- A FDA UDI
- Description
- V-Pin Needle Set_Triple FDA UDI
Identifiers
- Catalog Number
- FA.IN.0001 FDA UDI
- Primary DI / UDI-DI
- 08800039825276 FDA UDI
- 510(k) Number
- K180729 FDA UDI
- FDA Product Code
- MRW FDA UDI
- GMDN Term
- Bone marrow biopsy needle, single-use FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Category: Bone marrow biopsy needle, single-use
Faset by Dio Medical Co., Ltd. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone marrow biopsy needle, single-use.
- Bone Marrow Tray — Argon Medical Devices, Inc. · Class II
- Bone Marrow Tray — Argon Medical Devices, Inc. · Class I
- MEDBONE — Medax Unipersonale Srl · Class II
- Bone Marrow Biopsy — Argon Medical Devices, Inc. · Class I
- Monoject — Cardinalhealth · Class II
- MEDLOCK — Medax Unipersonale Srl · Class II
- Bone Marrow Biopsy Needle, RBN-116 — RANFAC CORP. · Class II
- BMN J TYPE — H.S. HOSPITAL SERVICE SPA · Class II
Cleared under the same submission
K180729 also covers:
- FaSet — Dio Medical Co., Ltd.
- FaSet — Dio Medical Co., Ltd.
- FaSet — Dio Medical Co., Ltd.
- FaSet — Dio Medical Co., Ltd.
- FaSet — Dio Medical Co., Ltd.
- FaSet — Dio Medical Co., Ltd.
- FaSet — Dio Medical Co., Ltd.
- Faset — Dio Medical Co., Ltd.
- Faset — Dio Medical Co., Ltd.
- Faset — Dio Medical Co., Ltd.
- Faset — Dio Medical Co., Ltd.
- Faset — Dio Medical Co., Ltd.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class U | Pending data |
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Manufacturer
- Manufacturer
- Dio Medical Co., Ltd.
Sources (1)
- FDA UDI e664170c-4b66-45bf-bbf7-a217fbdb560f 36 fields · synced May 31, 2026